Clinical research involving human subjects has come under increasing scrutiny in recent years, and as a consequence, has become the focus of increasing demands for oversight, enhanced protections, and increased education for those conducting the research. Institutions are now aware of the need to ensure greater patient protection, to promote patients' rights and the understanding of the research of which they are part of, and to train their investigative teams in the ethical as well as scientific aspects of human subjects research. However, these added procedures and safeguards create a burden for institutions in providing adequate resources. The NIH developed this S07 program to provide institutions conducting clinical research with infrastructure support for managing all aspect of clinical studies involving human subjects.

This award is intended to:

Provide short-term support for institutional activities that will strengthen oversight of human subjects research at institutions that receive significant NIH support for clinical research.

Support new human subject advocacy programs or to improve or expand existing programs

Program Description

Although there is considerable flexibility in the types of activities that could be supported under the S07 Human Subjects Research Enhancement Awards program, it is important that these projects enhance the protection of research subjects through projects that will be sustained by the institution after the award period ends. The scope of activity for this award may include, but is not limited to:

Development of educational initiatives for investigators, administrators and IRB members in the safe and ethical conduct of clinical research.

Development of educational initiatives for clinical trials participants, their families and the general public.

Computer or web-based systems to coordinate the activities of IRBs, to allow for the approval of consent forms used in multiple institutions, and to coordinating activities of multiple IRBs when participating in multi-center clinical trials.

The following links are available relating to Human Subjects Protections:

A database of all HSREA (S07) awards funded in FY 2002 and 2003 has been developed for public access. See below for running ad hoc queries. Just clicking the "Run Query" button without changing the default parameters will run a list of all Principal Investigators (PIs) at All Institutions in FY 2003. The "Select Individual(s)" drop-down box allows you to select "All Principal Investigators" (FY 2002, 2003 or both) or to select an individual investigator. You may also limit your search by selecting a specific Institution from the "Select Institution(s)" drop-down list, or by entering key words for searching Institution Names and Grant Titles. The "Contents of the Listing" defaults to "Selected Fields", or you may select "All Database Fields" for a more complete listing. Listings may be sorted by Investigator or Institution Name, Title or Grant Number. When desired parameters are selected, click the "Run Query" button to generate the list. The "Reset Fields" button will re-set all query fields to the original (default) parameters.

If your query finds more than one grant record, the resulting listing will display a summary table showing the Principal Investigator, Institution, Grant # and Grant Title. You may then click on the "Principal Investigator" name link to display detailed information about the PI, such as mailing address, phone, fax and e-mail. Links in the "Grant #" column lead to Grant Abstracts from Computer Retrieval of Information on Scientific Projects (CRISP) system. Other links may also be available, as provided by the PI. If your query finds only one record, it will take you directly to the grant detail screen showing PI information, as well as all other related links.

FY 2003 HSREA E-Mail Lists - Click this link to run E-mail distribution lists of FY 2003 HSREA Principal Investigators. This lists can be sent from your Browser e-mail or copied and pasted into your local e-mail program to facilitate communication among the HSREA community.

HSREA Contacts - Please send your questions, comments and/or updates relating to this HSREA page to one of the Programmatic or Grants Management Contacts listed on the HSREA Contacts page. Updated Grant/PI information is welcome. If you experience technical problems accessing site pages or links, or if you have general questions or comments about the OER Grants web site, please contact the OER Webmaster.

This web page is archived and provided for historical reference purposes only. The content and links are no longer maintained and may be outdated.
See the Archive Home Page for more details about archived files.